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临床试验/NCT01523665
NCT01523665已完成不适用

Evaluation of Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System

B. Braun Melsungen AG12 个研究点 分布在 9 个国家目标入组 508 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
508
试验地点
12
主要终点
Blood glucose values: Percentage of time within the chosen glucose target range of 4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l

研究概览

简要总结

Glucose metabolism is impaired in many critically ill patients and is often aggravated by parenteral feeding, infections and/or pre-existent diabetes.Therefore insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented on most critical care units. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. Several barriers to the implementation of glycemic control have been identified. Most importantly, there is concern about increased frequency of severe hypoglycemic episodes. To overcome these problems Space GlucoseControl was developed as a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges (4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l).

The objective of this non-interventional study is to gain additional information on the performance of the Space GlucoseControl system for glycaemic control in ICU patients when used in routine clinical practice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Blood glucose values: Percentage of time within the chosen glucose target range of 4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l

时间窗: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.

次要结局

  • Frequency of hypoglycaemic episodes(From start of treatment to the last glucose measurement under treatment, typically up to 14 days.)
  • Adherence to the advice of the Space GlucoseControl system(From start of treatment to the last glucose measurement under treatment, typically up to 14 days.)
  • Blood glucose measurement interval(From start of treatment to the last glucose measurement under treatment, typically up to 14 days.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (12)

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